Securing the pharmaceutical supply chain is of crucial importance to drug companies, suppliers, and consumers. The problem of supply-chain security has taken center stage with a number of recent initiatives.

Counterfeit drugs

Although the problem of counterfeit drugs traditionally has centered on solid dosage drugs, recent drug shortages for injectable cancer medications have triggered concerns over counterfeit versions of these types of drugs. In January 2012, FDA advised that current shortages of injectable cancer medications may present an opportunity for introduction of non-FDA approved products into the drug supply (1). FDA advised healthcare providers to obtain and use only FDA- approved injectable cancer medications purchased directly from the manufacturer or from wholesale distributors licensed in the United States.

FDA advised in January 2012 of promotions and sales of unapproved injectable cancer medications direct-to-clinics in the US, which most likely were administered to patients. Products purchased include a high percentage of sterile injectable medications and medications whose quality could be adversely affected if they are not stored or transported under specific temperatures. Examples of products include unapproved versions of FDA-approved medications, such as Faslodex (fulvestrant), Neupogen (filgrastim), Rituxan (rituximab) and Herceptin (trastuzumab).

In certain circumstances, FDA may authorize limited importation of medications that are in short supply. Such medications are imported from approved international sources and distributed in the US through a controlled network and would not be sold in direct-to-clinic solicitations. If FDA has arranged for limited importation of the foreign version of a medication, information on obtaining that medication is available on the FDA drug shortages website (1).

FDA's notification in January was followed by another problem of a counterfeit version of an injectable drug, Avastin (bevacizumab). In mid-February 2012, FDA warned healthcare professionals and patients about a counterfeit version of Roche's/Genentech's anticancer drug Avastin 400 mg/16 mL, which may have been purchased and used by some medical practices in the US. Avastin is an injectable medicine and is administered to patients in clinics, hospitals, and doctors' offices. The counterfeit version of Avastin does not contain the medicine's active ingredient, bevacizumab, which may have resulted in patients not receiving needed therapy (2).

In a related action, FDA issued letters to 19 medical practices in the US that purchased unapproved cancer medicines that may include the counterfeit Avastin. The counterfeit version is labeled as Avastin, manufactured by Roche. Roche is the company that manufactures Avastin approved for marketing outside of the US. The only FDA-approved version of Avastin for use in the US is marketed by Genentech (a member company of Roche). The FDA-approved version does not include the Roche logo on the packaging or vials. In addition, Genentech's FDA-approved version of Avastin vials and packaging have a 6-digit numeric batch number and expiration dates in a three-letter month and four-digit year format (e.g., JAN 2014). Genentech's Avastin products are safe and effective for their intended uses.

The 19 medical practices in the United States purchased unapproved cancer medicines and, potentially, the counterfeit Avastin, from Quality Specialty Products (QSP), a foreign supplier that may also be known as Montana Health Care Solutions, according to FDA documentation (2). Volunteer Distribution in Gainesboro, Tennessee, is a distributor of QSP's products. FDA requested that the medical practices stop using any remaining products from these suppliers. FDA cannot ensure the safety or efficacy of any of these unapproved products. Based on information to date, FDA determined that none of the unapproved cancer medicines received by these medical practices from Volunteer Distribution are in shortage in the US. FDA-approved versions of these medicines are available in adequate supply to meet current demand.